Clinical Research Specialist

SUMMARY OF POSITION: Under the direction of the Manager, Clinical Operations, the individual in this senior-level position conducts in-house and/or field clinical studies and prepares/maintains related clinical study files. This includes, but is not limited to, clinical site evaluation and selection, clinical site monitoring visits (e.g., initiation, interim and closeout) and preparation of related study correspondence and reports. This individual also utilizes clinical and/or engineering expertise to conduct in-house or field evaluations of NPB product performance.

2. ESSENTIAL FUNCTIONS:

'Represents Clinical Affairs Department on projects and other multi-functional teams.
'Independently develops Clinical Validation Strategies, Clinical Study Plans, and Clinical Protocols to evaluate the accuracy and clinical performance/acceptance of NPB products prior to product release.
'Strategically plans, implements and concludes complex clinical studies in support of project timelines/market release goals.
'Independently conducts and observes product testing and operation of equipment at NPB and customer/clinical sites.
'Independently utilizes the tools (including computer s/w and h/w) needed to perform job duties.
'Applies advanced understanding of Federal Regulations and international standards under which clinical studies of medical devices are conducted.
'Applies and may train others in applying critical thinking to complex clinical study problems.
'Designs and achieves personal training/education goals related to continued development of technical knowledge.
'Acts as clinical and/or technical expert/liaison on matters affecting accuracy and clinical performance of NPB products.
'Writes and may oversee others in writing clear, succinct clinical study documents to describe complex technical material.
'Provides guidance, coaching and training to Clinical Research Specialist I/II's.


MINIMUM REQUIREMENTS:

'Bachelor's degree or 3-5 years equivalent work experience required.
'4-8 years prior medical device industry experience required.
'Strong clinical background (e.g., respiratory therapy, nursing, pharmacology, or physiology) or engineering background preferred.
'Comprehensive knowledge of principles of clinical study design and research methodology.
'Ability to independently set and manage multiple priorities.
'Ability to apply, or assist others in applying, the appropriate level of detail to achieve project goals in a timely manner with attention to applicable regulations.
'Operates effectively as a team member or leader with an understanding of team dynamics; demonstrates ability to guide others in effectively executing work processes.
'Excellent oral and written communication skills.
'Proficiency with basic computer software applications (e.g., Microsoft Word, Excel).
'Ability to manually assemble, lift, and operate up to 10 pounds of instruments and computers on a regular basis to conduct product testing.


ORGANIZATIONAL RELATIONSHIPS/SCOPE:

This position reports to the Manager, Clinical Operations.

The individual in this position interacts closely with all Clinical Affairs department members (e.g., Clinical Research Specialists, Project Managers, and Laboratory personnel), within Respiratory Division.

This position also interacts closely with multidisciplinary R&D project team members.

This position has no direct budgetary responsibility.


WORKING CONDITIONS:

On-site work is performed in a standard office environment or in a controlled laboratory environment. Exposure to human blood and use of needles (for qualified, licensed personnel) may be required in the clinical laboratory. Up to 25-50% travel is required to clinical sites where work may be performed in a standard office environment or in a hospital or clinical environment. Lifting and transporting test equipment (up to 10 lbs.) may be required.




job Requirements


Please refer to the job description above.